Abstract 81P
Background
Colorectal cancer is one of the most common malignancies and the second leading cause of cancer-related death globally. Fruquintinib is an FDA-approved oral tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFRs) 1, 2, and 3, which showed promising efficacy in advanced colorectal cancer both alone and in combination with immunotherapy. Stereotactic body radiation therapy (SBRT) is emerging hope to achieve better resectability and local control. We report the preliminary results of SBRT followed by fruquintinib in combination with immunotherapy as third- and later-line treatment in metastatic colorectal cancer (mCRC).
Methods
Thirty patients with mCRC were expected to be enrolled. All the patients had received second- or later-line treatment for mCRC and had at least 1 measurable lesion per RECIST version 1.1. SBRT would be conducted as appropriate. One week later, fruquintinib would be administered with an oral daily dose of 3-5 mg on days 1-14 in combination with sintilimab 200 mg intravenously once for day 1 using a 21-day cycle. The treatment would continue until progressive disease or intolerable toxicity. The primary endpoint was PFS.
Results
To date, 22 patients had been enrolled, of whom 14 patients were male. The median age was 59 (range: 32-73) years. With a median follow-up of 8.50 months, 14 pts underwent post-baseline tumor assessment once at least. Two (14.29%) patients achieved partial response, twelve (85.71%) patients kept stable disease, and no patients had complete response or progressive disease. The objective response rate was 14.29% and the disease control rate was 100%. The median PFS and OS were still not reached, while the 6-month PFS rate were 42.86%. One patient died during the study. Treatment-related adverse events (TRAEs) were generally manageable and tolerable. The most common TRAEs were fatigue (n=9), hypertension (n=5), and hypothyroidism (n=5). 5 (22.7%) patients experienced G3/4 TRAEs.
Conclusions
SBRT followed by fruquintinib in combination with immunotherapy yielded a promising efficacy and acceptable safety as third- and later-line treatment in mCRC, which warrants further large-scale studies.
Clinical trial identification
ChiCTR2300071037.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.